The new ISO 11607-01 standard, which is the foremost guidance document for validating packaging for terminally sterilized medical devices, has only just been published. Changes to this standard will impact compliance requirements for validating medical device packaging.

“DDL West has found that there is little awareness in California about the true implications of the revised ISO 11607 standard,” said Michael Foster, DDL West Package Engineer. “This is why DDL West is hosting a series of Webinars on the topic and is making an effort to clearly communicate with customers the exact requirements that their packaging will be expected to meet.”

Following the first two Webinars in the ISO 11607 Revisions series, DDL received many questions from participants concerned with preparing their medical device packaging for testing under the new ISO 11607-01 standard.

The most pressing questions asked included:

• Is it necessary to re-do previous validations to comply with the new standard?
• Is it compulsory to perform distribution simulation?
• What are the benefits of separating stability from performance testing?

“Hosting the ISO 11607 Revisions Webinars has really opened our eyes to how little information there is out there about changing industry requirements,” said Foster. “This is why we decided to make our customers’ most pressing questions (along with the answers) available on the DDL website.”

You can also register for an ISO 11607 Revisions Webinar on our website.

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